Kehua Bio-engineering

Shanghai Kehua Bio-engineering Co., Ltd. (referred to as "Kehua Bio-engineering") was founded in 1981, with its headquarters in Shanghai. It was listed on the Shenzhen Stock Exchange in 2004 (stock code: 002022.SZ), being the first listed company in China's in-vitro diagnostics (IVD) industry. Through strategic investments and overseas mergers and acquisitions, the group currently owns nearly 40 subsidiaries and employs nearly 2,000 staff, with R&D and production bases in Xi'an, Suzhou, the Greater Bay Area, Italy, and South Korea.
Kehua Bio-engineering focuses on five major fields: immunodiagnostics, clinical chemistry, molecular diagnostics, mass spectrometry, and point-of-care testing (POCT), aiming to provide integrated IVD solutions of "reagents + instruments + services." The company was the first in China to develop and launch enzyme immunoassay products for hepatitis B and C and liquid dual reagents for clinical chemistry, and it is also one of the first enterprises in China to obtain drug certificates for nucleic acid blood screening products. Driven by innovation, the group continuously improves its product portfolio, having independently developed over 100 testing instruments and more than 700 diagnostic reagents. Its products have obtained over 300 domestic medical device registrations and filings, and over 600 international registrations and certifications including EU CE and US FDA.
Having been deeply engaged in the industry for over 40 years, the group has always adhered to independent R&D and innovation, and has successively won numerous honors such as the National Science and Technology Progress Second Prize, the Shanghai Science and Technology Award, and the National Intellectual Property Demonstration Enterprise. It also hosts a post-doctoral research workstation, the Shanghai Enterprise Technology Center, the Shanghai Engineering Technology Research Center for Immunodiagnostic Reagents, and the Shanghai In-Vitro Diagnostic Reagent Technology Innovation Center.
Through collaborations with numerous research institutes and top-tier hospitals, including the Chinese Academy of Sciences, Tsinghua University, Shanghai Jiao Tong University, Fudan University, Peking Union Medical College Hospital, and Xijing Hospital, the group has led and participated in over a hundred national, provincial, and municipal key research projects, including the National Key R&D Program, the National Major Scientific Instruments and Equipment Development Special Project, the National Major Special Project for Infectious Disease Prevention, and the National 863 Program, with related products achieving strategic transformation.
Rooted in China and expanding globally, the company's business covers tens of thousands of medical institutions, blood centers, disease control centers, and research institutes both domestically and internationally, widely serving clinical diagnosis, blood screening, public health, food safety, and scientific research. While consolidating the domestic market, it also accelerates the internationalization process. Products are exported to over 100 countries and regions, among which its self-developed AIDS diagnostic reagents have obtained WHO PQ certification and are listed in the procurement catalogs of multiple organizations and countries, including UNICEF and USAID. The company has established in-depth strategic cooperation with leading international enterprises in the industry, promoting R&D innovation and product iteration through collaborative mechanisms such as joint technology development and resource sharing.
Looking to the future, Kehua Bio-engineering will continue to uphold the mission of "Caring for Life, Pursuing Excellence," with the vision of becoming a mainstay in the IVD field, adhering to the values of "Customer First, Innovation and Collaboration, Responsibility and Pragmatism," continuously promoting precision medicine development, and contributing Kehua's strength to human health.